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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002660-70 | EudraCT Number |
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This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
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| Group 2: Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
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| Group 3: Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
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| Group D: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB054707 | Drug | INCB054707 75 mg will be administered orally on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter: Cmax of INCBC054707 | Defined as maximum observed plasma concentration of INCB054707 | Days 1 - 5 |
| Pharmacokinetics Parameter: AUC(0-t) of INCB054707 | Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707. | Days 1 - 5 |
| Pharmacokinetics Parameter: AUC(0-∞) of INCB054707 | Defined as area under the concentration-time curve From 0 to Infinity of INCB054707 | Days 1 - 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAE'S) | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | up to 15 days |
| Pharmacokinetics Parameter: tmax of INCB054707 |
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Inclusion Criteria:
- Participants with hepatic impairment will be classified at screening based on Child-Pugh score. Classification will be repeated at check-in and should not be significantly different.
If the hepatic function classification for the participant is not similar at the 2 timepoints, enrollment of the participant into a hepatic category group will be at the discretion of the investigator, in consultation with the sponsor's medical monitor. The enrollment group will be based on the results at screening.
Exclusion Criteria:
the opinion of the principal investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating hepatic function.
Serum corrected calcium and phosphorus levels over the upper limits of the institutional normal ranges.
History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
A current, functioning organ transplant or a scheduled organ transplant in the next 6 weeks from check-in.
History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
Severe ascites (ascites requiring paracentesis more than every 4 weeks) or an encephalopathy ≥ Grade 2 (precludes them from understanding and signing an informed consent).
Any major surgery within 4 weeks of screening.
Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
Blood transfusion within 4 weeks of check-in.
Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in.
Positive serology for HBV (eg, HBsAg) or HIV. Participants whose results are compatible with immunity due to infection or prior immunization for HBV may be included at the discretion of the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Orlando Clinical Research Center |
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open label study
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Defined as time to reach maximum plasma concentration of INCB054707
| Days 1 - 5 |
| Pharmacokinetics Parameter: t1/2 0f INCB054707 | Defined as apparent terminal phase disposition half-life of INCB54707 | Days 1 - 5 |
| Pharmacokinetics Parameter: CL/F of INCB054707 | Defined as oral dose clearance of INCB054707 | Days 1 - 5 |
| Pharmacokinetics Parameter:: Vz/F of INCB054707 | Defined as apparent oral dose volume of distribution of INCB054707 | Days 1 - 5 |
| Orlando |
| Florida |
| 32809 |
| United States |
| Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office | San Antonio | Texas | 78215 | United States |
| Apex Gmbh | Munich | D-81241 | Germany |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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